Tag: medical
CMS’s Final “Sunshine” Rule: Implications for Research
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Physician Payment Sunshine Act” (Sunshine Act or Act).[1] The Sunshine Act was included in ACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of certain products (federally reimbursable drugs and biologicals as well as covered medical devices and medical supplies), and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Final Rule details requirements for processing and reporting payments by pharmaceutical, device, biological, and medical supply “applicable manufacturers”[2] to physicians and teaching hospitals that are “covered recipients.”[3] The Final Rule also sets forth requirements for reports of ownership and investment interests held … Read More »
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »
Patent War Between St. Jude Medical and Volcano Has Mixed Results
St. Jude Medical and Volcano have been embroiled in a legal battle over patents held by both companies, related to pressure wire technology that is used for heart patients. The battle began over two years ago when St. Jude Medical sued Volcano, in Delaware district court, for infringement of 5 of its patents for pressure guide wire products. The patents in suit were U. S. Patent No. 5,938,624, U.S. Patent No. 6,196,980, U.S. Patent No. 6,112,598, U.S. Patent No. 6,167,763 and U.S. Patent No. 6,248,083. St. Jude requested an injunction and damages for infringement of the five asserted patents.
Volcano replied by counterclaiming, alleging that St. Jude Medical had infringed four of its own patents, but later dropped one of those patents from the suit. The three remaining patents asserted by Volcano against St. Jude were U.S. Patent No. 6,976,965, U.S. … Read More »
Electronic Health Records: Looking Past Skepticism
With more instances of Electronic Health Record (EHR) data breaches popping up in the news, skepticism is beginning to build as to whether or not the health care industry can handle the switch from paper to digital. In the most recent incident, The Surgeons of Lake County, located in northern Chicago, fell victim to a data breach by hackers who were able to gain access to e-mails and electronic medical records. Adding to the nation’s interest in this specific incident, the hackers have encrypted the data, holding it “hostage” for ransom from the health care facility. The hackers are demanding payment in exchange for a password that will allow doctors to regain access to their patients’ electronic health records.
Aside from data breaches, EHRs have come under fire for other kinks and flaws related to their implementation. In late July, a … Read More »
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »
Social Medicine?
It isn’t difficult to see that the main impact of social media penetration in our culture is an epidemic of oversharing. Americans under the age of 25 have a very different approach to privacy than, say, your average 30 year-old, and feel weirdly comfortable sharing details of their private lives. E-mail is considered to be outlandishly formal, large scale sharing over social networks and texting is commonplace, and the barriers between personal and institutional communication are nearly non-existent.
This has led, predictably, to mass sharing of medical information online — even two years ago, news organizations were reporting on the rise of “e-patients” who talk to medical experts and amongst themselves in order to obtain treatment, piece of mind and/or the thrill of exposure.
Suddenly, there is widespread information about adverse outcomes and side effects, in every search that someone does for … Read More »
Jesse Witten featured on Inside Counsel
On August 3, 2012, Jesse Witten published an article on his thoughts on Eucomed’s code of ethics.
To read the entire article, click here.
Medical Device Security: How Safe is Wireless Technology?
The health care industry has seen a jump in the number of medical devices that use wireless technology. With this rapid technologic development comes concern about the safety, security and privacy of patients. There is specific concern in this regard with respect to the following commonly used devices: Implantable Medical Devices (IMDs), External Medical Devices, and Portable Devices.[i]
Last year a security researcher successfully demonstrated how an outside breach of a wireless insulin pump allows for the hacker to shut off or alter the settings of the device. This poses a serious risk for those with portable and implantable medical devices that are controlled via wireless technology. In addition to a breach of control of these devices, the risk of malware on such FDA-approved medical devices is also a concern. In the event that an FDA-approved medical device is infected with … Read More »
U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »